This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF administered subcutaneously. The second focus will be to detail the global immune response by measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be to investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells. The results of this trial will generate supportive human data to use GLA as an adjuvant in a dendritic cell-targeted vaccine strategy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
17
Glucopyranosyl Lipid A (GLA) in an aqueous formulation (AF).
Glucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE).
The same stable oil-in-water emulsion (SE), but without GLA.
Rockefeller University
New York, New York, United States
Safety
Local reactogenicity events and systemic reactogenicity events will be monitored for 28 days post injection. * Local reactogenicity events include tenderness, erythema, skin discoloration, edema, vesicle formation or ulceration, induration, pruritus, formation of a crust or scab, or other. * Systemic reactogenicity events include fever, chills, headache, nausea, vomiting, malaise, myalgia, arthralgia, and rash. Long term safety will be monitored by follow-up phone calls at 3 months, 6 months, and 1 year post injection.
Time frame: 1 year
Immunogenicity
Describe the global immune response by measuring systemic cytokines, chemokines and global gene regulation. Investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells.
Time frame: 28 days
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